Senior GMP QC Compliance Specialist

This is a fully remote position, open to applicants in Puerto Rico.

📋 Description

• Act as the main compliance authority integrated within the QC laboratory, ensuring that all analytical and quality control activities related to mRNA and biologics manufacturing adhere completely to relevant GxP regulations, internal quality standards, and international regulatory expectations.

• Serve as a strategic compliance partner to QC laboratory management, promoting a culture of quality and continuous improvement across all QC operations.

• Offer expert advice on regulatory requirements, lead initiatives for audit preparedness, manage quality management system activities, and act as a mentor and subject matter expert (SME) for QC laboratory personnel.

• Maintain inspection readiness at all times and uphold the integrity of data produced in support of product release, stability, and method lifecycle activities.

⛳️ Requirements

• At least 5 years of progressive experience in pharmaceutical or biopharmaceutical QC, Quality Assurance, or a combined QC/QA compliance role.

• Proven experience in supporting QC laboratory operations within a GMP-regulated biologics or mRNA environment.

• A solid track record of managing regulatory inspections (FDA, EMA, or equivalent) and internal audits in a QC laboratory context.

• Practical experience with deviation management, CAPA systems, change control, deviations, investigations, and quality management systems in a regulated pharmaceutical setting.

• Experience in authoring and reviewing GxP-compliant documentation including SOPs, validation protocols/reports, and regulatory submission materials.

• Comprehensive knowledge of relevant regulatory frameworks: FDA 21 CFR Parts 211, 600–680; EU GMP Guidelines (Annex 1, 2, 11, 15); ICH Q2(R2), Q6B, Q10, Q11, Q14; PIC/S.

• Strong comprehension of data integrity principles and regulatory expectations.

🏝️ Benefits

• Competitive salaries.

• Medical, dental, and vision coverage.

• 401K retirement savings plan (100% vested immediately in the employer match).

• Life, disability, and voluntary benefits.

• Paid time off for holidays, sick leave, and vacation days.

• Health Savings Account (HSA).

• Wellness program.

• Flexible spending accounts.

• Tuition reimbursement.

• Employee Assistance program.

• Parental leave.

• Optional legal coverage and identity theft protection.